FDA report lays quality-control accusations to rest for Mylan

PITTSBURGH The Food and Drug Administration has released its official and final report of a generic drug maker’s manufacturing plant after its quality control was brought into question by a newspaper.

Last month, the Pittsburgh Post-Gazette made accusations that a Morgantown, W.Va. manufacturing facility owned by Mylan had ignored and deleted computerized warnings of problems with drugs and the equipment used to manufacture them, according to leaked internal documents.

The newspaper article was based on improperly obtained documents, uninformed third-party commentary and anonymous sources, Mylan said. The final FDA report closes the inspection with no deficiencies found and no FDA “483” issued.

“Mylan’s manufacturing facilities — especially our plant in Morgantown — have always represented the gold standard when it comes to quality,” said Mylan CEO Robert Coury. “Without ever getting complacent, our entire management team and all of our employees continue to demonstrate an unyielding commitment to sustain the highest of quality standards. I would like to thank all of our employees for their continued hard work and execution, and I am pleased that this investigation is formally behind us.”